Arrowhead Reports Fiscal 2014 Second Quarter Financial Results
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Fiscal 2014 Second Quarter and Recent Company Highlights
- Began dosing patients in a Phase 2a study of lead candidate ARC-520 against chronic hepatitis B infection;
- Completed first dose cohort in ARC-520 Phase 2a study;
Completed an equity financing with gross proceeds of
Scheduled an analyst and R&D Day for
June 19in New York Cityto discuss our next clinical candidate for a rare liver indication;
- Upgraded NASDAQ listing to the Global Select Market;
- Hired additional R&D staff in key areas, including manufacturing, toxicology, chemistry, biology, quality assurance, and regulatory and clinical operations to support rapid development of ARC-520 and additional clinical candidates.
Selected Fiscal 2014 Second Quarter Financial Results
Net loss attributable to Arrowhead for the quarter was
Total operating expenses for the quarter were
Net cash used in operating activities for the first six months of fiscal
The company's cash and investments of cash were
Common shares outstanding at
Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead's DPC delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. Arrowhead has completed enrollment in a Phase 1 single ascending dose study in normal volunteers. The company is conducting a single dose Phase 2a study in chronic HBV patients, which it expects to follow with a multi-dose, multi-national Phase 2b study. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers.
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Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in any
forward-looking statements as a result of various factors and
uncertainties, including our ability to finance our operations, the
future success of our scientific studies, our ability to successfully
develop drug candidates, the timing for starting and completing clinical
trials, rapid technological change in our markets, and the enforcement
of our intellectual property rights.
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